Highly sensitive LC-MS method for stereochemical quality control of a pharmaceutical drug substance intermediate.
Sign Up to like & getrecommendations! Published in 2022 at "Chirality"
DOI: 10.1002/chir.23435
Abstract: Stereochemical quality control for pharmaceutical drug substance intermediates is a daunting task, especially considering the need to separate multiple stereoisomers simultaneously with low ppm level sensitivity. To address these challenges, we have successfully implemented chiral… read more here.
Keywords: quality control; drug substance;
Tackling quantitative polymorphic analysis through fixed-dose combination tablets production. Pyrazinamide polymorphic assessment.
Sign Up to like & getrecommendations! Published in 2020 at "Journal of pharmaceutical and biomedical analysis"
DOI: 10.1016/j.jpba.2020.113786
Abstract: Pyrazinamide (PZA), Rifampicin (RIF), Isoniazid (ISH) and Ethambutol (ETB) form the core for the treatment of Tuberculosis, today a devastating disease in low-income populations around the world. These drugs are usually administrated by fixed-dose combination… read more here.
Keywords: fdc tablets; drug substance; dose combination; form ... See more keywords
Impact of Freeze/Thaw Process on Drug Substance Storage of Therapeutics.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2017.03.019
Abstract: The storage of drug substance at subzero temperatures mitigates potential risks associated with liquid storage, such as degradation and shipping stress, making it the best solution for long-term storage. However, slower (generally uncontrolled) rates of… read more here.
Keywords: drug; drug substance; freeze thaw; storage ... See more keywords
The Botanical Drug Substance Crofelemer as a Model System for Comparative Characterization of Complex Mixture Drugs.
Sign Up to like & getrecommendations! Published in 2017 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2017.07.012
Abstract: Crofelemer is a botanical polymeric proanthocyanidin that inhibits chloride channel activity and is used clinically for treating HIV-associated secretory diarrhea. Crofelemer lots may exhibit significant physicochemical variation due to the natural source of the raw… read more here.
Keywords: drug substance; crofelemer; drug; model ... See more keywords
The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2019.04.008
Abstract: Prasugrel hydrochloride is the active ingredient in Effient™, a thienopyridine platelet inhibitor. An extensive study of the degradation chemistry of prasugrel hydrochloride (LY640315 hydrochloride) has been carried out on the drug substance (part I) and… read more here.
Keywords: degradation; drug substance; prasugrel; chemistry ... See more keywords
Synthesis and control of process-related impurities in the β-lactamase inhibitor drug substance zidebactam
Sign Up to like & getrecommendations! Published in 2023 at "Synthetic Communications"
DOI: 10.1080/00397911.2023.2209677
Abstract: Abstract Zidebactam is a novel extended spectrum β-lactamase inhibitor (ESBLI). It’s combination with cefepime (WCK 5222) is in phase III clinical studies. Five process impurities were found in zidebactam (1) drug substance using process development… read more here.
Keywords: lactamase inhibitor; synthesis control; drug substance; process ... See more keywords
Development, Robustness by Design Expert and Validation of a Method for Enantiomeric Impurity Content Determination in Pretomanid Drug Substance and Pharmaceutical Dosage Form.
Sign Up to like & getrecommendations! Published in 2022 at "Journal of chromatographic science"
DOI: 10.1093/chromsci/bmac090
Abstract: For the purpose of identifying enantiomeric impurities in the drug substance and pharmaceutical dosage forms of the novel anti-TB medication pretomanid, an RP-high-performance liquid chromatography method was devised. To ensure the robustness of the optimized… read more here.
Keywords: substance pharmaceutical; pharmaceutical dosage; drug substance; robustness ... See more keywords
A Validated GC-MS Method for the Determination of Genotoxic Impurities in Divalproex Sodium Drug Substance.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of chromatographic science"
DOI: 10.1093/chromsci/bmy089
Abstract: A specific GC-MS method has been developed, optimized and validated for the determination of five genotoxic impurities namely Methyl bromide (Me.-Br), Ethyl bromide (Et.-Br), Isopropyl bromide (Ipr.-Br), n-Propyl bromide (n-Pr.-Br) and n-Butyl bromide (n-But.-Br) in… read more here.
Keywords: determination; drug substance; divalproex sodium; genotoxic impurities ... See more keywords
An Orthogonal Approach for Determination of Acetamide Content in Pharmaceutical Drug Substance and Base-Contaminated Acetonitrile by GC and GC-MS External Method.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of chromatographic science"
DOI: 10.1093/chromsci/bmz077
Abstract: Acetamide is a potential genotoxic impurity; it should control in drug substance based on daily dosage level. It forms from base-contaminated acetonitrile and by-product of some drug substances. The available methods for acetamide in drug… read more here.
Keywords: drug; contaminated acetonitrile; drug substance; base contaminated ... See more keywords
Identification of Degradation Products of the New Anticancer Drug Substance ONC201 by Liquid Chromatography–High-Resolution Multistage Mass Spectrometry
Sign Up to like & getrecommendations! Published in 2023 at "Chemosensors"
DOI: 10.3390/chemosensors11050294
Abstract: ONC201 (dordaviprone) is a new drug substance used in a compassionate manner to treat patients with glioblastoma. Given the clinical context and the particularly promising preclinical results, we have been asked by the medical authorities… read more here.
Keywords: liquid chromatography; high resolution; drug substance; chromatography high ... See more keywords